Regulatory Affairs Manager

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Job title: Regulatory Affairs Manager

Company: Philips

Job description: Job Title Regulatory Affairs Manager

Job Description

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to

Drive remediation program to resolve findings from APS&Q assessment in technical file and catch-up 510k’s. New 510k’s and submissions for business-critical MR Coil programs. Drive the project teams to deliver submission ready information on time (meeting Regulatory requirements).

You are responsible for

  • Work according to the business applicable processes and as ambassador of the Philips values.
  • Train regulatory resources in their development.
  • Exercise supervision in terms of schedules, methods and staffing for projects leading
  • Establishes operational objectives and work plans, and delegates assignments to project team members.
  • Keeps abreast of current regulatory procedures and changes
  • Key role in external and internal audits related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.
  • (support)Reviews and recommends changes for labeling, and clinical protocols to maintain regulatory compliance.
  • Responsible for developing and implementing global regulatory and roadmaps though deep understanding of the competitive market landscape, regulatory/ legislative initiatives, and product marketing strategy for their responsible products within business portfolio
  • Responsible for product registrations/approvals in her/his field.
  • Leads regulatory resources as part of projects (s)he works in.

You are a part of

You will be a team member of the global Philips regulatory organization. The team you will be working in, is a high-performance, culturally diverse, and very dynamic.

To succeed in this role, you should have the following skills and experience

  • Minimal of 8 years of experience in the medical device industry and technical environment with at least 3 years in an Imaging Diagnostic medical device company( FDA Class II equivalent – Class III a plus)
  • Must have experience with successful preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide
  • Strong background in Design Controls
  • Excellent working knowledge of Standards like IEC62304/82304/60601
  • Excellent working knowledge of medical device regulations (21CFR), FDA Law, MDD, MDR, other global laws and regulations.
  • Experience in supporting international registrations and clinical investigations(as a plus)
  • Approx. 5% travel annually with some international.
  • Bachelor’s degree in a technical/quality/law/pharma discipline
  • RAPS certified (as a plus)

In return, we offer you

  • A rewarding career in Philips with attractive package.

Extensive set of tools to drive your career, such as a personal development budget, training and coaching.

Attractive collective health insurance package.

Opportunity to buy Philips shares and products with discount

How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There’s a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

#LI-PHILIN

Expected salary:

Location: Pune, Maharashtra

Job date: Wed, 26 Oct 2022 02:56:12 GMT

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